Versions :<1 2 Live

FDA to Increase Oversight of Lab Tests

Published SEP 30 2023

story

Image credit: Unsplash

The Spin

Pro-establishment narrative

Unregulated laboratory-developed tests, which have long skirted FDA oversight, pose a growing risk to patients because of potentially inaccurate results. The proposed rule would end decades of regulatory ambiguity and ensure the tests are safe, accurate, and reliable.

ProPublica

Establishment-critical narrative

Before it tries to close the so-called loophole that has allowed laboratory-developed tests to bypass oversight for decades, the FDA must prove it has the authority to regulate these tests and examine the potential impact of its proposed regulation on the diagnostic industry.

Senate